BEUDAMED
    35 results · 28ms · Sources: EU EUDAMED, US FDA

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    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER INC·Product code LPB·August 30, 2023

    UNKNOWN COOL TIP ELECRTRODE

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·April 19, 2024

    Medline Strider Midi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mudelein, IL 60060 USA; model MDS807550 - red and MDS807550B - blue

    FDA Recall
    Terminated ·Medline Industries Inc·Product code INI·July 20, 2006

    Medline Strider Midi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mudelein, IL 60060 USA; model MDS807500 - red and MDS807500B - blue

    FDA Recall
    Terminated ·Medline Industries Inc·Product code INI·July 20, 2006

    MINI MED

    FDA Adverse Event
    Injury ·MINI MED INC·Product code LZG·December 11, 2000

    MINIMED INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MINI MED INC.·Product code LZG·January 18, 2001

    ALLIGATOR GRASPER

    FDA Adverse Event
    Malfunction ·MINI LAP TECHNOLOGIES INC.·Product code KOG·June 30, 2014

    ALLIGATOR GRASPER

    FDA Adverse Event
    Malfunction ·MINI LAP TECHNOLOGIES INC.·Product code KOG·June 30, 2014

    ALLIGATOR GRASPER

    FDA Adverse Event
    Malfunction ·MINI LAP TECHNOLOGIES INC.·Product code KOG·June 30, 2014

    MINI LAP INSTRUMENTS

    FDA Adverse Event
    Injury ·MINI LAP TECHNOLOGIES INC.·Product code KOG·September 10, 2009

    MINILAP ALLIGATOR GRASPER

    FDA Adverse Event
    Malfunction ·MINI LAP TECHNOLOGIES INC.·Product code KOG·June 13, 2011

    ALLIGATOR GRASPER

    FDA Adverse Event
    Malfunction ·MINI LAP TECHNOLOGIES INC.·Product code GCJ·July 30, 2010

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    FDA Adverse Event
    Malfunction ·MINI LAP TECHNOLOGIES INC STRYKER·Product code GCJ·November 17, 2010

    Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.

    FDA Enforcement
    Class III ·Terminated·Zimmer Surgical Inc·May 20, 2015

    CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States.

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc·May 11, 2016

    VIOS

    FDA Adverse Event
    Malfunction ·PARI RESPIRATORY EQUIPMENT, INC. - MIKE JUDGE·Product code CAF·November 6, 2020

    MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

    FDA Enforcement
    Class II ·Terminated·Mivi Neuroscience Inc·September 15, 2021

    MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

    FDA Enforcement
    Class II ·Terminated·Mivi Neuroscience Inc·September 15, 2021

    Angionautix S.L.

    Importer
    🇪🇸 Spain·2 Manufacturers

    Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.

    FDA Enforcement
    Class II ·Terminated·Orthoscan, Inc.·January 17, 2018